FDA Selects GCP Over DOH for Research Conducted Outside U.S.

Posted by Amy Davis, program director

Last year the U.S. Food and Drug Administration (FDA) ended the need for clinical trials conducted outside of the U.S. to comply with the Declaration of Helsinki (DOH). Now, such research must be conducted in accordance with Good Clinical Practices (GCP) of the International Conference on Harmonization.

Critics of this change describe it as a “major victory of corporate interests” since it arguably weakens the ethical standards for international clinical trials, making it easier to conduct research outside the US than inside. An additional criticism is that the change creates new inconsistencies among international policies related to human subjects research and puts further out of reach the universal goal for a harmonious, global system of regulation of biomedical research. Many countries rely on the Declaration of Helsinki as a basis for their research policies. Allowing US companies to conduct research in those countries, that is not compliant with this document, creates inconsistent ethical standards for the research conducted there.

Critics of the revised FDA regulations also highlight several differences between the DOH and the GCP. They say the GCP principles allow placebo-controlled clinical trials, while the DOH requires new drugs to be tested against “the best current prophylactic, diagnostic, and therapeutic method.” They also point out that the GCP does not address conflicts of interest, the need to publish results, or the tested drug’s post-trial availability to research subjects.

However, the FDA justifies the change because the GCP principles provide more specific guidance on how to design research trials, monitor safety, and report adverse events, all of which ultimately offer greater protections for human subjects.

Most of us who work in the field of human subjects research are aware of the importance of the DOH as a foundational policy for the ethical conduct of biomedical research. Inspired in part by the horror of the Nazi experiments revealed during the Nuremberg Trials, the DOH was developed and adopted by the World Health Association in 1964. The document has been revised (most recently in November 2008) six times since its first adoption to keep up with technological advances and scientific discovery, but remains the most widely used set of ethical principles that guide the protection of human subjects in biomedical and social research. The DOH is cited in research policies adopted throughout the world, and many scholarly journals prohibit the publication of papers based on research that was not conducted in compliance with the DOH.

So we wonder:

Do you think the revised FDA regulations allow U.S. sponsors to conduct research more easily outside the U.S. than inside?

If so, does this lead to the unjust treatment of research subjects?

Are the GCP standards sufficient and appropriate for the protection of human subjects in research?

How important is the harmonization of ethical principles in the conduct of international research?

Let us know your thoughts either on this blog or through our discussion forums (members only).

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